A Safety Study of SGN-CD19A for Leukemia and Lymphoma

This study is currently recruiting participants.
Verified March 2014 by Seattle Genetics, Inc.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01786096
First received: February 5, 2013
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

This is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and tolerability of SGN-CD19A in adult and pediatric patients with relapsed or refractory B-lineage acute lymphoblastic leukemia (B-ALL), Burkitt lymphoma or leukemia, or B-lineage lymphoblastic lymphoma (B-LBL).


Condition Intervention Phase
Burkitt Lymphoma
Precursor B-cell Lymphoblastic Leukemia-Lymphoma
Drug: SGN-CD19A
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With B-Lineage Acute Lymphoblastic Leukemia and Highly Aggressive Lymphomas

Resource links provided by NLM:


Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: Through 1 month post last dose ] [ Designated as safety issue: Yes ]
  • Incidence of laboratory abnormalities [ Time Frame: Through 1 month post last dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Objective response according to modified response criteria for acute myeloid leukemia (Cheson 2003) or revised response criteria for malignant lymphoma (Cheson 2007) [ Time Frame: Through 1 month post last dose ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Until disease progression or start of new anticancer treatment, an expected average of 3 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Until death or study closure, an expected average of 6 months ] [ Designated as safety issue: No ]
  • Blood concentrations of SGN-CD19A and metabolites [ Time Frame: Cycles 1, 2, and 4: predose, 30 minutes, and up to 2, 4, 8, 24, 72, 120, 168, and 336 hours post dose start; All other cycles: predose, 30 minutes, and 168 and 336 hours post dose start; and 1 month post last dose ] [ Designated as safety issue: No ]
  • Incidence of antitherapeutic antibodies [ Time Frame: Predose in most cycles and 1 month post last dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 175
Study Start Date: February 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SGN-CD19A
SGN-CD19A (IV) once (Day 1) or twice (Days 1 and 8) every 21 days; dose range: 0.3-6 mg/kg
Drug: SGN-CD19A
SGN-CD19A (IV) once (Day 1) or twice (Days 1 and 8) every 21 days; dose range: 0.3-6 mg/kg

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients must be relapsed or refractory to at least 1 prior multi-agent systemic therapy. Pediatric patients must be relapsed or refractory to at least 2 prior multi-agent systemic therapies. Patients with acute lymphoblastic leukemia who are Philadelphia chromosome-positive must have failed a second generation tyrosine kinase inhibitor.
  • Eastern Cooperative Oncology Group status of 2 or lower
  • Pathologically confirmed diagnosis of B-lineage acute lymphoblastic leukemia, Burkitt leukemia or lymphoma, or B-lineage lymphoblastic lymphoma
  • Measurable disease

Exclusion Criteria:

-Allogeneic stem cell transplant within 60 days, active acute or chronic graft-versus-host disease (GvHD), or receiving immunosuppressive therapy as treatment for GvHD

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01786096

Contacts
Contact: Terri Lowe 866-333-7436 clinicaltrials@seagen.com

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294-3300
Contact: Stephanie Biggers    205-975-2944    sbiggers@uab.edu   
Principal Investigator: Uma Borate         
University of Alabama at Birmingham / Children's Hospital of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Julia Adams    205-638-2984    jadams@peds.uab.edu   
Principal Investigator: Joseph Pressey, M.D.         
United States, Arizona
Mayo Clinic Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Pamela McClure    480-301-4963    mcclure.pamela@mayo.edu   
Principal Investigator: Raoul Tibes, M.D.         
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Joel Conrad    626-256-4673    jconrad@coh.org   
Principal Investigator: Robert Chen, M.D.         
United States, Florida
Mayo Clinic Cancer Center Recruiting
Jacksonville, Florida, United States, 32224
Contact: Mayo Clinic Clinical Trials ReferralOffice    507-538-7623      
Principal Investigator: James Foran, MD         
All Children's Hospital Recruiting
St. Petersburg, Florida, United States, 33701
Contact: Jennifer Flanary    727-767-6466    Jennifer.Flanary@allkids.org   
Principal Investigator: Gregory Hale, M.D.         
H. Lee Moffitt Cancer Center & Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Debra Mimo    813-745-7362    Debra.Mimo@moffitt.org   
Principal Investigator: Bijal Shah, M.D.         
United States, Georgia
Children's Healthcare of Atlanta / Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Lauren Zahra    404-785-0275    lauren.zahra@choa.org   
Principal Investigator: Todd Cooper, D.O.         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Meghan Burke    617-643-5126    MBURKE19@PARTNERS.ORG   
Principal Investigator: Amir Fathi, M.D.         
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Hilary Hall    617-632-6829    HilaryN_Hall@dfci.harvard.edu   
Principal Investigator: Lewis Silverman, M.D.         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Alexandra Savell    617-582-8287    Alexandrae_savell@dfci.harvard.edu   
Principal Investigator: Daniel DeAngelo, M.D.         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Afra Yehwalashet    646-888-5841    yehwalaa@mskcc.org   
Principal Investigator: Tanya Trippett, M.D.         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Courtney Blank    513-803-3255    Courtney.Blank@cchmc.org   
Principal Investigator: Maureen O'Brien, M.D.         
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Director: Tina Albertson, MD, PhD Seattle Genetics, Inc.
  More Information

No publications provided

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01786096     History of Changes
Other Study ID Numbers: SGN19A-001
Study First Received: February 5, 2013
Last Updated: March 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:
Burkitt Lymphoma
Antibodies, Monoclonal
Antibody-Drug Conjugate
B-Lineage Acute Lymphoblastic Leukemia
B-Lineage Lymphoblastic Lymphoma
Burkitt Leukemia
Monomethylauristatin F
Antigens, CD19
Drug Therapy

Additional relevant MeSH terms:
Burkitt Lymphoma
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoma, B-Cell
Neoplasms, Experimental
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014